Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device accessories, soft lens products
Product CodeLPN
Regulation Number 886.5928
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL OPTICS INC
  SUBSTANTIALLY EQUIVALENT 1
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALLERGAN, INC
  SUBSTANTIALLY EQUIVALENT 1
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 5
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 2
CACHET PHARMACEUTICALS PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 2
CHEMTEX USA INC.
  SUBSTANTIALLY EQUIVALENT 1
CHEMTEX USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENICON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MENICON CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
OPTICS LABORATORY, INC
  SUBSTANTIALLY EQUIVALENT 1
OPTICS LABORATORY, INC.
  SUBSTANTIALLY EQUIVALENT 1
OTE NORTH AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
SAUFLON PHARMACEUTICALS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
THE LIFESTYLE COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 105 105
2015 176 176
2016 498 498
2017 2665 2665
2018 95 95
2019 60 60
2020 82 82
2021 50 50
2022 62 62
2023 85 85
2024 62 64

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 2897 2897
Adverse Event Without Identified Device or Use Problem 396 397
Improper or Incorrect Procedure or Method 119 119
Insufficient Information 78 78
Device Operates Differently Than Expected 73 73
Device Markings/Labelling Problem 65 65
Patient-Device Incompatibility 54 54
Inadequate Instructions for Non-Healthcare Professional 33 33
Contamination 32 32
Device Emits Odor 32 32
Packaging Problem 28 28
Use of Device Problem 27 27
Appropriate Term/Code Not Available 17 17
Labelling, Instructions for Use or Training Problem 17 17
Material Integrity Problem 17 17
Leak/Splash 12 12
Device Handling Problem 11 11
Off-Label Use 8 8
Contamination /Decontamination Problem 8 8
Manufacturing, Packaging or Shipping Problem 6 6
Device Contamination with Chemical or Other Material 5 5
Patient Device Interaction Problem 5 5
Microbial Contamination of Device 5 5
No Apparent Adverse Event 5 5
Device Expiration Issue 5 5
Nonstandard Device 5 5
Improper Chemical Reaction 4 4
Contamination of Device Ingredient or Reagent 4 4
Defective Device 4 4
Break 4 4
Crack 4 4
Fluid/Blood Leak 3 3
Unexpected Therapeutic Results 3 3
Fungus in Device Environment 3 3
Protective Measures Problem 3 3
Incomplete or Missing Packaging 3 3
Output Problem 3 3
Inadequate User Interface 2 2
Inappropriate or Unexpected Reset 2 2
Chemical Problem 2 2
Defective Component 2 2
Component Missing 2 2
Expiration Date Error 2 2
Difficult to Remove 2 2
Device Inoperable 1 1
Difficult to Open or Close 1 1
Metal Shedding Debris 1 1
Accessory Incompatible 1 1
Difficult or Delayed Activation 1 1
Physical Property Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 2815 2815
Red Eye(s) 549 549
Pain 390 390
Irritation 344 344
Discomfort 176 177
Blurred Vision 151 151
Excessive Tear Production 149 149
Eye Burn 106 106
Keratitis 100 100
Corneal Ulcer 100 100
Conjunctivitis 97 98
Swelling 95 95
Dry Eye(s) 80 80
No Code Available 74 74
No Consequences Or Impact To Patient 74 74
Itching Sensation 73 73
Corneal Abrasion 63 63
Eye Pain 57 58
Unspecified Infection 56 56
Caustic/Chemical Burns 56 56
Inflammation 56 56
Eye Injury 52 52
Loss of Vision 46 46
Hyperemia 45 46
No Known Impact Or Consequence To Patient 45 45
Erythema 43 43
Foreign Body Sensation in Eye 37 37
Visual Disturbances 35 35
Visual Impairment 34 34
Reaction 34 34
No Clinical Signs, Symptoms or Conditions 30 30
Chemical Exposure 29 29
Burn(s) 28 28
Eye Infections 27 27
Corneal Edema 27 27
Corneal Scar 26 26
Headache 23 23
Discharge 22 22
Corneal Clouding/Hazing 16 16
Hypersensitivity/Allergic reaction 16 17
Increased Sensitivity 16 16
Corneal Infiltrates 15 15
Erosion 15 15
No Patient Involvement 14 14
Acanthameba Keratitis 14 14
Fungal Infection 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Swelling/ Edema 12 12
Halo 12 12
Bacterial Infection 12 12

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics Inc (AMO) II Nov-02-2010
2 Allergan PLC II Feb-03-2021
3 Bausch & Lomb Inc II Nov-10-2009
4 Bausch & Lomb Inc II Aug-13-2009
5 Bausch & Lomb Inc Irb II Nov-21-2016
6 Family Dollar Stores, Llc. II Aug-17-2022
7 Marietta Vision III Mar-04-2011
8 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
-
-